April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
A Double-Masked, Randomised, Placebo-Controlled Trial of Intravitreal Triamcinolone Prior to Laser Treatment of Diabetic Macular Edema
Author Affiliations & Notes
  • M. C. Gillies
    Ophthatlmology, University of Sydney, Sydney, Australia
  • I. McAllister
    Lions Eye Institute, Perth, Australia
  • M. Zhu
    Ophthatlmology, University of Sydney, Sydney, Australia
  • A. Islam
    Centre for Eye Research Australia, Melbourne, Australia
  • D. Louis
    Ophthatlmology, Centre For Eye Research Australia, Melbourne, Australia
  • J. Arnold
    Marsden Eye Specialists, Sydney, Australia
  • T. Wong
    Centre for Eye Research Australia, Melbourne, Australia
  • Footnotes
    Commercial Relationships  M.C. Gillies, None; I. McAllister, None; M. Zhu, None; A. Islam, None; D. Louis, None; J. Arnold, None; T. Wong, None.
  • Footnotes
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 1678. doi:
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      M. C. Gillies, I. McAllister, M. Zhu, A. Islam, D. Louis, J. Arnold, T. Wong; A Double-Masked, Randomised, Placebo-Controlled Trial of Intravitreal Triamcinolone Prior to Laser Treatment of Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1678.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To report the 12-month outcomes from a clinical trial of intravitreal triamcinolone (IVTA) 4mg vs. placebo prior to laser treatment in eyes with diabetic foveal edema and impaired vision (≤20/30).

Methods: : 84 eyes of 54 participants were entered into the study, with 42 eyes initially receiving IVTA and 42 placebo, 6 weeks prior to standard laser treatment. Further laser was applied according to prospectively defined criteria. 12 month data were available for 72/84 (86%) eyes; 12 eyes of 10 patients were lost to follow-up (7 eyes received IVTA and 5 placebo) . For the eyes with missing 12-month data the last observation was carried forward. Main outcome measures were improvement of best-corrected LogMAR visual acuity after 12 months compared with baseline and incidence of adverse events. Secondary outcomes were requirement for further laser and change in central macular thickness

Results: : Mean visual acuity was well matched between the IVTA and placebo treated groups at baseline 55.5 (11.2 [SD]) vs. 55.2 (12.4) letters and had changed by the same amount after 12 months: -0.50 (0.67) vs. -0.50 (0.94) letters. Mean foveal thickness had decreased significantly (P=0.001 for both) in both groups by 12 months compared with baseline, and was somewhat more pronounced in the IVTA-treated group (135 vs 86 micron, P=0.06). Visually significant cataract (≥ 2+ AREDS posterior subcapsular grade) developed in 16 (37%) IVTA treated eyes vs 2 (4%) placebo-treated eyes (P<0.001); three of these cataracts were removed before the 12 month visit. Glaucoma therapy was used in 20 (48%) in IVTA group versus 19 (45%) eyes in placebo group. Further laser treatment was required in 24 (57%) IVTA-treated eyes vs. 26 (62%) placebo-treated eyes.

Conclusions: : Visual results at 12 months were no better in the IVTA-treated group, although further analysis of 2 year-outcomes after visually significant cataract has been removed is warranted to determine whether a beneficial effect was masked by the development of cataract. The adverse event profile of IVTA was similar to previous reports. Reducing diabetic macular edema prior to laser treatment with IVTA does not appear to reduce the need for further laser

Clinical Trial: : www.clinicaltrials.gov NCT00148265

Keywords: diabetic retinopathy • corticosteroids • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 

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